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The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design
Benjamin J Powers1, Joy L King, Robin Ali
1Center for Health Services Research in Primary Care, Durham VAMC, Durham, NC 27705, USA. ben.powers@duke.edu
Insights
This study will test a nurse-led intervention to improve cardiovascular disease (CVD) outcomes in African American adults with diabetes by managing blood pressure, blood sugar, and cholesterol.
Area of Science:
- Public Health
- Cardiology
- Endocrinology
Background:
- Cardiovascular disease (CVD) and diabetes contribute significantly to mortality disparities between African Americans and white patients.
- African Americans exhibit a higher CVD risk due to clustered risk factors.
Purpose of the Study:
- To enhance CVD outcomes in African-American adults with diabetes.
- To address modifiable risk factors: systolic blood pressure, glycosylated hemoglobin, and low-density lipoprotein cholesterol.
Main Methods:
- 400 African American patients with diabetes were randomized into two groups: usual care or a nurse-administered disease-management intervention.
- The intervention included monthly telephone support, patient self-management, and provider medication management.
- Outcomes were assessed over 12 months, focusing on changes in glycosylated hemoglobin, systolic blood pressure, and LDL cholesterol.
Main Results:
- The study aims to measure changes in key cardiovascular risk factors over a 12-month period.
- Secondary outcomes include overall cardiovascular risk, aspirin use, and health behavior modifications.
Conclusions:
- The proposed study has the potential to significantly reduce cardiovascular risk in African-American patients.
- Addressing racial disparities in CVD is a critical public health goal.
Background:
Cardiovascular disease (CVD) and diabetes account for over one third of the mortality difference between African Americans and white patients. The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors.
Objectives:
The current study is aimed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin, and low-density lipoprotein cholesterol.
Methods:
A sample of African American patients with diabetes (N = 400) will receive written education material at baseline and be randomized to one of 2 arms: (1) usual primary care or (2) nurse-administered disease-management intervention combining patient self-management support and provider medication management. The nurse administered intervention is delivered monthly over the telephone. The nurses also interacts with the primary care providers at 3, 6, and 9 months to provide concise patient updates and facilitate changes in medical management. All patients are followed for 12 months after enrollment. The primary outcomes are change in glycosylated hemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol over 12-months. Secondary outcomes include change in overall cardiovascular risk, aspirin use, and health behaviors.
Conclusion:
Given the continued racial disparities in CVD, the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients.
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